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FDA Panel Votes Against Breast Cancer Drug

PITTSBURGH (KDKA) — For breast cancer that has spread to other parts of the body, some women take the drug Avastin.

A local grandmother is one of them, getting the IV treatment every three weeks.

So what does she think about the Food and Drug Administration considering revoking its approval?

“It almost makes you lose hope, then. If you’re taking something that’s going to help you, you think why are they taking it off you?” asks Marlene Dagen of Center Township.

The initial approval in 2008 was fast-tracked and based on a single study.

Since then, five randomized controlled trials of 3,500 patients showed no significant improvement in overall survival or quality of life. There’s also an increased risk of ruptured intestines, bleeding and death.

“Patients lived longer without their disease getting worse, but none of them showed that overall survival was actually better,” explains Dr. Jane Raymond, a breast cancer specialist at Allegheny General Hospital. “So the FDA and the expert panel is saying, ‘Well if you can’t show you can’t prolong survival, then the drug isn’t worth it.’”

About 17,000 American women take this medicine, which is a protein thought to stop blood vessel growth in tumors.

“Patients think, well, ‘This is my lifeline.’ On the other hand, there aren’t studies that prove that the Avastin was actually keeping them disease free,” Dr. Raymond continues. “So I always explain to them we don’t really have the information and that we’re doing that because everybody thought it might be helpful.”

Doctors could still prescribe Avastin without FDA approval, but insurance wouldn’t cover it. It can cost up to $100,000 a year.

If Avastin is no longer an option, women can still get chemo and hormones. Perhaps someday, with genetic testing of cancers, the people who would benefit most from the drug could be identified.

“I hope they find the appropriate place for Avastin, because I think there is a spot,” says Dr. Raymond.